Differential Study of Invasive Pituitary Adenomas in the Sellar and Cavernous Sinus Regions

This study involves collecting paired tumor samples from intrasellar and cavernous sinus regions of 20 invasive pituitary tumor patients, preserving them at -80°C for quality multi-omics analysis. Proteomics and transcriptomics are employed to identify molecular differences, while imaging data (MRI/CT) assesses tumor morphology and invasion. In vitro experiments and mechanistic studies validate key findings, exploring how regional molecular differences affect tumor behavior. Data integration combines multi-omics and imaging features to uncover biomarkers and pathways associated with invasiveness and regional specificity, with statistical analysis ensuring significance and reliability.

Study Overview

• Status: Recruiting
• Conditions: Pituitary Tumor
• Intervention / Treatment: Other: surgery

Detailed Description

This study focuses on investigating the molecular and biological differences between the intrasellar and cavernous sinus regions in invasive pituitary tumors to uncover mechanisms driving their aggressiveness and to identify potential therapeutic targets.

The research begins with sample collection, selecting 20 patients with invasive pituitary tumors based on inclusion and exclusion criteria. Paired tumor tissue samples are collected from the intrasellar and cavernous sinus regions of each patient, ensuring accuracy and completeness. These samples are then preserved at -80°C to maintain quality for subsequent multi-omics analyses.

Next, multi-omics analysis is conducted to examine molecular differences. Proteomics, using technologies like mass spectrometry or protein arrays, identifies differentially expressed proteins between the two regions and assesses their biological functions. Transcriptomics, through RNA sequencing, explores significant differences in gene expression and associated pathways. These approaches aim to uncover molecular mechanisms driving the tumor's invasive behavior.

Imaging analysis complements the molecular studies by utilizing preoperative imaging data, such as MRI or CT, to evaluate tumor morphology, invasion depth, and the impact on surrounding tissues. This provides a structural and functional context for the molecular findings.

Biological experiments follow to validate key discoveries. In vitro studies using cell lines or organoid models test the role of specific genes or pathways identified in the omics analyses, such as through gene knockout or overexpression. Mechanistic studies focus on understanding how molecular differences between the intrasellar and cavernous sinus regions influence tumor behaviors like invasion, proliferation, and migration. Validation experiments, including Western blotting or immunofluorescence, confirm the expression patterns and regional specificity of significant molecules.

Finally, data integration and analysis combine findings from proteomics, transcriptomics, and metabolomics with imaging features. Bioinformatics tools integrate these datasets to identify biomarkers and pathways associated with the tumor's invasiveness and regional specificity. Imaging-omics integration links molecular profiles with imaging characteristics, while rigorous statistical analysis ensures the robustness and significance of the results, accounting for potential confounding factors.

This comprehensive approach aims to provide new insights into the biological mechanisms of invasive pituitary tumors and identify effective targets for innovative therapeutic strategies.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Tao Xie; Phone Number: +8613524281211; Email: xie.tao@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital Fudan University
      • Contact: Tao Xie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-80 years who are clinically diagnosed with invasive pituitary tumors involving the cavernous sinus, have signed the informed consent form, and are willing to participate in this study.

Description

Inclusion Criteria:

1. Invasive pituitary tumors involving the cavernous sinus
2. Retrospective inclusion of patients who have signed informed consent forms for the donation of biological samples and health-related information
3. Age range: 18-80 years
4. Subjects are willing to participate in this study

Exclusion Criteria:

1. Non-invasive pituitary tumors
2. Pregnant or breastfeeding
3. Other conditions deemed unsuitable for participation in this clinical trial as assessed by the physician

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pituitary tumors in cavernous sinus group; The 20 pituitary tumor samples in this group were obtained from the cavernous sinus region removed during surgery and were paired with pituitary tumors in the intralellar region	Other: surgery; Samples were obtained from patients by surgical excision and matched into groups
pituitary tumors in sellar group; The 20 pituitary tumors in this group were obtained from intrasellar samples removed during surgery and were paired with pituitary tumors in the cavernous sinus region	Other: surgery; Samples were obtained from patients by surgical excision and matched into groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in pathological features of tumors	Cell morphology, proliferation index (e.g. Ki-67), angiogenesis, and other pathological features of tumor tissue in different regions were analyzed to explore region-specific invasive manifestations	2025/12/01-2026/12/01

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Director: Tao Xie, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 23, 2024
• First Submitted That Met QC Criteria: November 23, 2024
• First Posted (Estimated): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 23, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: cavernous sinus; intrasellar
• Additional Relevant MeSH Terms: Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Endocrine Gland Neoplasms; Neoplasms, Glandular and Epithelial; Nervous System Neoplasms; Central Nervous System Neoplasms; Hypothalamic Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Adenoma; Pituitary Neoplasms; Pituitary Diseases
• Other Study ID Numbers: KY2024683

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No